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Home  /   Forum   /   Pharming   /   Pharming februari 2023

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,738   -0,020   (-2,57%) Dagrange 0,736 - 0,763 3.727.215   Gem. (3M) 4,8M

Pharming februari 2023

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4.234 Posts
Pagina: «« 1 ... 199 200 201 202 203 ... 212 »» | Laatste | Omlaag ↓
  8. forum rang 7 LL 27 februari 2023 12:44
    CSL's Phase 3 Study Shows First-In-Class Garadacimab Provides Patients with Significant HAE Attack Prevention with Monthly Dosing
    CSL Logo

    News provided by
    CSL

    Feb 26, 2023, 10:45 ET

    Majority of patients were attack free during the entire six-month treatment period (61.5%)
    Study results presented for first time at 2023 AAAAI Annual Meeting; global regulatory submissions anticipated later in the calendar year
    Garadacimab underscores CSL's promise to develop innovative medicines for people living with rare diseases like HAE, a community CSL has been serving for 40 years

    KING OF PRUSSIA, Pa., Feb. 26, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today presented results from the pivotal placebo-controlled Phase 3 VANGUARD clinical trial of garadacimab (CSL312). Garadacimab is CSL's investigational first-in-class monoclonal antibody being developed as a long-term prophylactic treatment for patients with hereditary angioedema (HAE). Results from the trial, the first to investigate targeting activated Factor XII (FXIIa) to prevent HAE attacks, showed that once-monthly subcutaneous injections of garadacimab significantly reduced the attack rate compared to placebo. The data were presented during the 2023 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting, February 24-27, in San Antonio, Texas.

    "Targeting FXIIa and the HAE cascade from the start, as opposed to intervening downstream, is an innovative treatment approach that could help stop the process in its tracks," said Dr. Timothy Craig, Tenured Professor of Medicine, Pediatrics and Biomedical Sciences at Penn State University and Principal Investigator of the study. "The Phase 3 data we are presenting support the potential use of garadacimab as a prophylactic therapy for HAE."

    Key Data from the Phase 3 VANGUARD Trial
    During the double-blind, randomized, placebo-controlled, multicenter, parallel-group study, patients taking once monthly garadacimab (n=39) experienced a statistically lower monthly attack rate versus placebo (n=24) (p< 0.001), resulting in a mean attack rate reduction of 86.5% versus placebo, and a median attack rate reduction of 100% versus placebo. The mean attack rate reduction compared with placebo after adjusting for baseline attack rate was 89.2%.

    Overall, during the six-month trial, a majority (61.5%) of patients taking garadacimab were attack-free whereas no patients on the placebo arm were attack-free; 74.4% of patients taking garadacimab achieved =90% attack reduction versus the run-in period.

    The study also showed that garadacimab demonstrated a favorable safety and tolerability profile. There were no adverse events that led to treatment discontinuation. Five injection site reactions, all mild, were reported in two (5.1%) patients treated with garadacimab and three patients (12%) on placebo.

    "The data being shared at AAAAI showcase the efficacy and safety profile of garadacimab administered as a convenient monthly subcutaneous injection. The clinical trial results support garadacimab as a novel, first-in-class potential treatment that could offer a significant benefit to patients with HAE," said Catherine Milch, Vice President R&D Immunology, CSL. "Garadacimab represents the next chapter in delivering on our promise to bring disruptive innovation and treatment options to patients living with rare diseases."

    Based on the full study data, which are consistent with the positive top line results announced in August 2022, CSL plans regulatory submissions to global health authorities later this calendar year for approval of garadacimab.

    About the Pivotal Phase 3 VANGUARD Trial
    The multicenter, randomized, double-blind, parallel-group VANGUARD trial evaluated the efficacy and safety of garadacimab, an investigational first-in-class monoclonal antibody, as a prophylactic treatment for patients with hereditary angioedema. Patients aged 12 years and older with HAE type I or II underwent screening and a run-in study period to verify a baseline attack rate. Patients were randomized 3:2 to receive a loading dose of 400mg followed by 200 mg of garadacimab monthly (n=39) or volume matched placebo monthly (n=25) subcutaneously. After the six-month treatment period, patients were given the opportunity to continue into the open-label extension study, which is currently ongoing.

    The ongoing open-label extension of the Phase 3 VANGUARD study evaluates the long-term safety and efficacy of garadacimab (200 mg monthly) in patients with HAE.

    About HAE and Garadacimab
    HAE is a rare, genetic and potentially life-threatening condition that causes painful, debilitating and unpredictable episodes of swelling of the abdomen, larynx, face and extremities, among other areas of the body.

    Garadacimab is a novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) currently in Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. Garadacimab uniquely inhibits the plasma protein, FXIIa. When FXII is activated, it initiates the cascade of events leading to edema formation. By targeting FXIIa, garadacimab inhibits the HAE cascade at its origin as compared with other HAE therapies that target downstream mediators.

    Garadacimab was discovered and optimized by scientists at CSL's Bio21–based Research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility.

    Orphan-drug designation for garadacimab as an investigational therapy for hereditary angioedema has been granted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

    CSL is also investigating garadacimab for other indications beyond HAE, including idiopathic pulmonary fibrosis, where FXIIa inhibition may play an important role in improving clinical outcomes.

    About CSL
    CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

    Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.

    For more information about CSL, visit www.CSL.com.

    bron:
    www.prnewswire.com/news-releases/csls...
  13. forum rang 5 uitzender 27 februari 2023 13:33
    Mooi artikel in het FD de communicatie van Pharming draait op volle toeren en er is het volste vertrouwen dat L. Goed gekeurd gaat worden in de USA.
    Natuurlijk is niets zeker behalve dan dat de EMA nog geen besluit heeft genomen en we daar wat langer op moeten wachten en we van de FDA voor 29 maart horen en mijn verwachting op basis hoe alles verloopt is nog altijd dat ze L. Gaan goed keuren en dan zal de EMA later het jaar ook wel goedkeuring gaan geven.
    Pharming heeft een uitstekend ingevoerde RVC in de VS en die zullen hun kennis en ervaring nu laten zien en alles in goede banen leiden voor een goedkeuring.
  14. forum rang 6 pakman 27 februari 2023 13:48
    LL,...Overall, during the six-month trial, a majority (61.5%) of patients taking garadacimab were attack-free whereas no patients on the placebo arm were attack-free; 74.4% of patients taking garadacimab achieved =90% attack reduction versus the run-in period.

    wil totaal niks zeggen, CSL geef ons de andere data vd mensen die meededen aan de Trials zijnd e : Leeftijd/man/vrouw/hoe vaak aanvallen /week/mnd /jaar

    CSL give us the other data of people who participated in the Trials being : Age/male/female/how many attacks /week/month /year
  15. forum rang 5 Jinxter 27 februari 2023 13:57
    quote:

    uitzender schreef op 27 februari 2023 13:33:

    Mooi artikel in het FD de communicatie van Pharming draait op volle toeren en er is het volste vertrouwen dat L. Goed gekeurd gaat worden in de USA.
    Natuurlijk is niets zeker behalve dan dat de EMA nog geen besluit heeft genomen en we daar wat langer op moeten wachten en we van de FDA voor 29 maart horen en mijn verwachting op basis hoe alles verloopt is nog altijd dat ze L. Gaan goed keuren en dan zal de EMA later het jaar ook wel goedkeuring gaan geven.
    Pharming heeft een uitstekend ingevoerde RVC in de VS en die zullen hun kennis en ervaring nu laten zien en alles in goede banen leiden voor een goedkeuring.
    Zal het vanavond eens rustig doorlezen in het FD.

    Cheers
  17. forum rang 5 Louis7 27 februari 2023 14:01
    quote:

    uitzender schreef op 27 februari 2023 13:33:

    Mooi artikel in het FD de communicatie van Pharming draait op volle toeren en er is het volste vertrouwen dat L. Goed gekeurd gaat worden in de USA.
    Natuurlijk is niets zeker behalve dan dat de EMA nog geen besluit heeft genomen en we daar wat langer op moeten wachten en we van de FDA voor 29 maart horen en mijn verwachting op basis hoe alles verloopt is nog altijd dat ze L. Gaan goed keuren en dan zal de EMA later het jaar ook wel goedkeuring gaan geven.
    Pharming heeft een uitstekend ingevoerde RVC in de VS en die zullen hun kennis en ervaring nu laten zien en alles in goede banen leiden voor een goedkeuring.
    Van welke datum is dit artikel van het FD?
4.234 Posts
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